Defining research with human subjects sbe id 491

CITI Program HSR Catalog Rev. 17 June 2015

Human Subjects Research (HSR) Series CITI Program’s HSR series consists of modules from two basic tracks, Biomedical (Biomed) and Social-Behavioral-Educational (SBE), and a set of Additional Modules of Interest. Organizations may group these modules to form a basic Biomed or SBE course, or a course that combines the two tracks. The Additional Modules of Interest should be used in any course variation, if relevant.

The basic Biomed modules have three corresponding sets of refresher modules and the basic SBE modules have two corresponding sets of refresher modules. These refresher modules are intended to provide learners with a review of what was covered in the basic level modules. It is generally recommended that organizations select refresher module requirements that reflect their selections for the basic course(s). Refresher courses should be taken in a cycle at an interval specified by your organization (for example, Refresher Stage 1: 3 years after completion of basic course; Refresher Stage 2: 6 years after completion of basic course).

Three additional standalone courses are available: Institutional/Signatory Official: Human Subject Research, and IRB Chair. The Institutional/Signatory Official: Human Subject Research course provides a general introduction to the roles and responsibilities of the institutional official at an organization holding a Federalwide Assurance (FWA). The IRB Administration course offers members of an Institutional Review Board’s (IRB) administrative office a comprehensive review of the critical areas associated with IRB, human research protection program (HRPP), and HRPP/IRB office operations. The IRB Chair course provides detailed training for current and future IRB chairs.

This catalog provides a listing and description of each module within the HSR series, as well as their recommended use, continuing education (CE) eligibility, and language availability.

CITI Program HSR Catalog Rev. 17 June 2015

Table of Contents

BASIC COURSE OPTIONS

HUMAN SUBJECTS RESEARCH – BIOMEDICAL (BIOMED) MODULES 1

HUMAN SUBJECTS RESEARCH – SOCIAL-BEHAVIORAL-EDUCATIONAL (SBE) MODULES 9

HUMAN SUBJECTS RESEARCH – ADDITIONAL MODULES OF INTEREST 15

REFRESHER COURSE OPTIONS

HUMAN SUBJECTS RESEARCH – BIOMEDICAL (BIOMED) REFRESHER 1 26

HUMAN SUBJECTS RESEARCH – BIOMEDICAL (BIOMED) REFRESHER 2 29

HUMAN SUBJECTS RESEARCH – BIOMEDICAL (BIOMED) REFRESHER 3 32

HUMAN SUBJECTS RESEARCH – SOCIAL-BEHAVIORAL-EDUCATIONAL (SBE) REFRESHER 1 35

HUMAN SUBJECTS RESEARCH – SOCIAL-BEHAVIORAL-EDUCATIONAL (SBE) REFRESHER 2 37

INSTITUTIONAL/SIGNATORY OFFICIAL: HUMAN SUBJECTS RESEARCH COURSE

INSTITUTIONAL/SIGNATORY OFFICIAL: HUMAN SUBJECTS RESEARCH COURSE 39

IRB CHAIR COURSE

IRB CHAIR COURSE 41

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Basic Course Options For a basic course in the HSR series, organizations may select modules from the Biomedical (Biomed) track, Social-Behavioral-Educational (SBE) track, and set of Additional Modules of Interest. For recommendations on how to set up a basic course using HSR modules, see the Using CITI Program Content: Human Subjects Research (HSR) document. In order to meet the needs of subscribing institutions, the CITI Program can assist administrators in creating courses that best meet their institutional needs, including combining modules from across the CITI Program. To discuss course recommendations that combine modules from different CITI Program offerings, please contact the CITI Program Help Desk at (305) 243-7970.

Human Subjects Research – Biomedical (Biomed) Modules These modules provide an introduction to biomedical research with a focus on the protection of human subjects. They offer historic and current information on regulatory and ethical issues important to the conduct of research involving human subjects.

Continuing Education (CE) Credits and Units These modules hold the following credit designations:

• Physicians: Up to 9 AMA PRA Category 1 Credits TM • Psychologists: 9 CEP Credits • Nurses: 6 CNE Credits/Contact Hours • Other Participants: Up to 9 AMA PRA Category 1 Credits TM

Credit Designation Period:

• Physicians, Psychologists, and Other Participants: 1 July 2013 to 30 June 2016 • Nurses: 2 December 2013 to 2 December 2016

Module Title Recommended Use

Belmont Report and CITI Course Introduction Required

History and Ethics of Human Subjects Research Required

Basic Institutional Review Board (IRB) Regulations and Review Process

Required

Informed Consent Required

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Social and Behavioral Research (SBR) for Biomedical Researchers

Required

Records-Based Research Required

Genetic Research in Human Populations Required

Populations in Research Requiring Additional Considerations and/or Protections

Required

Vulnerable Subjects - Research Involving Prisoners Supplemental

Vulnerable Subjects - Research Involving Children Required

Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates

Supplemental

Avoiding Group Harms - U.S. Research Perspectives Elective

Avoiding Group Harms - International Research Perspectives Elective

FDA-Regulated Research Required

Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research

Required

Research and HIPAA Privacy Protections Required

Belmont Report and CITI Course Introduction This module provides a link to the Belmont Report. It also offers additional information regarding the CITI Program’s website and the availability of the Belmont Report in English, Chinese, Spanish, and French.

Language Availability English (ID: 1127) Spanish (ID: 16459) Korean (ID: 15895) Russian (ID: 16303) French (ID: 16448) Khmer (ID: 16273) Vietnamese (ID: 16241) Tamil (ID: 16384)

History and Ethics of Human Subjects Research This module discusses ethical principles for the conduct of research involving human subjects. It provides an overview of the historical events that influenced the development of the current regulatory requirements, a review of the Belmont Principles, and a discussion of

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the contemporary ethical standards that guide research today. Language Availability English (ID: 498) Spanish (ID: 1478) Portuguese (ID: 1507) Korean (ID: 15924)

Basic Institutional Review Board (IRB) Regulations and Review Process IRBs are a standard within the area of human subjects research. This module provides basic information about the human subject protection regulations and IRBs, including the role, authority, and composition of the IRB. The information presented is based on the Common Rule as codified by the U.S. Department of Health and Human Services (HHS) at 45 CFR 46. The different types of IRB review processes are discussed, providing the learner with an overview of the essential issues associated with exempt, expedited, and full (convened) IRB reviews. This module concludes with a discussion of the other regulations and requirements (such as the U.S. Food and Drug Administration [FDA] and the International Conference on Harmonisation [ICH]) and regulatory groups (for example, the National Institutes of Health [NIH] and the Department of Education [DOE]) that require compliance based on certain types of research.

Language Availability English (ID: 2) Spanish (ID: 1479) Portuguese (ID: 1508) Korean (ID: 15923) Chinese (ID: 1588) Khmer (ID: 15546) Vietnamese (ID: 15884)

Informed Consent The process and documentation of informed consent are fundamental tenets of human subjects research. It is important for researchers to understand these concepts. To that end, this module provides the learner with the framework for informed consent found within the Common Rule. Some of the special challenges associated with informed consent are also discussed, including informed consent as it relates to vulnerable populations. The module concludes with a review of the requirements for waiver of informed consent as well as the differences between U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS) regulations.

Language Availability English (ID: 3) Spanish (ID: 12194) Portuguese (ID: 1509) Korean (ID: 15926) Chinese (ID: 1589)

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Khmer (ID: 16248) Vietnamese (ID: 15885)

Social and Behavioral Research (SBR) for Biomedical Researchers Because biomedical researchers employ a variety of SBR techniques within the framework of biomedical research, it is important to understand the nature, risks, and benefits associated with these techniques. This module discusses the types of studies that utilize SBR techniques, along with the kinds of data collected. A review of some of the risks and benefits that are unique to SBR completes the course.

Language Availability English (ID: 4) Spanish (ID: 1718) Korean (ID: 15927) Chinese (ID: 1590) Khmer (ID: 16250) Vietnamese (ID: 15886)

Records-Based Research Researchers may make important advances in the fields of education, medicine, psychology, and public policy by using previously collected information that does not involve prospective interaction with human subjects. Records-based research has its own risks, and researchers who propose to conduct such research must have an understanding of those risks and how to minimize them. As a compliment to that review, this module also provides learners with an overview of the types of review processes required for records-based research. This overview includes the questions that must be addressed in order to make the appropriate determinations with respect to review.

Language Availability English (ID: 5) Spanish (ID: 1490) Korean (ID: 15928) Chinese (ID: 1591) Khmer (ID: 16329) Vietnamese (ID: 16242)

Genetic Research in Human Populations Although continued advancements in genetic research present exciting opportunities in biomedicine, they also present some of the most difficult challenges with respect to the protection of human subjects. This module begins with an introduction to the types and complexity of genetic research. The learner is then provided with a review of ethical, legal, and regulatory issues associated with genetic research. A discussion of the issues surrounding the use of stored biological samples concludes this module.

Language Availability English (ID: 6)

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Spanish (ID: 1672) Korean (ID: 15929) Chinese (ID: 1592) Khmer (ID: 16254) Vietnamese (ID: 15887)

Populations in Research Requiring Additional Considerations and/or Protections This module provides an introduction to potentially vulnerable populations or those requiring additional protections and/or considerations in research. It describes different sources of vulnerability and distinguishes between populations in research who are specifically protected in the federal regulations and those who are not. The module also discusses the impact on autonomy, beneficence, and justice that may arise due to research on or with vulnerable individuals or groups.

Language Availability English (ID: 16680) Spanish (ID: 1483) Korean (ID: 15930) Chinese (ID: 1593) French (ID: 16447) Khmer (ID: 16258) Vietnamese (ID: 15888)

Note: This module does not hold CE credit designation.

Vulnerable Subjects - Research Involving Prisoners This module describes the special requirements for conducting research with prisoners. The learner is provided with a review of why incarcerated individuals need special protection, as well as the regulatory definition of what constitutes a prisoner. This module also includes a discussion of each of the permitted categories for research involving prisoners and the required IRB considerations and determinations. The module concludes with the topic of what happens if an enrolled subject becomes a prisoner.

Language Availability English (ID: 8) Spanish (ID: 1482) Korean (ID: 15931) Chinese (ID: 1594) Vietnamese (ID: 16550)

Vulnerable Subjects - Research Involving Children This module describes the major historical events that influenced how research with children can be conducted. It describes problems with this type of research that may violate ethical standards. It reviews the assent and informed consent requirements, and the current efforts by the U.S. Food and Drug Administration (FDA) to ensure the inclusion of children in studies on the safety and efficacy of new drugs. An overview of the categories of research involving children is provided, including examples.

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Language Availability English (ID: 9) Spanish (ID: 1498) Portuguese: (ID: 12822) Korean (ID: 15932) Chinese (ID: 1595) Vietnamese (ID: 16551)

Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates This module describes the historical exclusion of women of childbearing potential and the special requirements for conducting research involving pregnant women and fetuses. It includes a discussion of each of the permitted categories for research involving the pregnant women, human fetuses, and neonates, as well as Institutional Review Board (IRB) review requirements and determinations. Informed consent requirements associated with the different categories of research permitted with pregnant women and human fetuses are also discussed.

Language Availability English (ID: 10) Spanish (ID: 1499) Portuguese: (ID: 12821) Korean (ID: 15933) Chinese (ID: 1598) Vietnamese (ID: 16552)

Avoiding Group Harms - U. S. Research Perspectives This module is designed for U.S. research perspectives and describes some distinct groups or communities of people who are vulnerable to group harms. In addition, learners are presented with examples of research that has caused group harms. This module concludes with strategies that researchers can take to reduce the risk of group harms.

Language Availability English (ID: 14080) Spanish (ID: 1719) Korean (ID: 15934) Chinese (ID: 1599) Khmer (ID: 16269) Vietnamese (ID: 16118)

Avoiding Group Harms - International Research Perspectives This module is designed for international research perspectives and describes some distinct groups or communities of people who are vulnerable to group harms. In addition, learners are presented with examples of research that has caused group harms. This module concludes with strategies that researchers can take to reduce the risk of group harms.

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Language Availability English (ID: 14081) Korean (ID: 15935) Vietnamese (ID: 16554)

FDA-Regulated Research This module addresses U.S. Food and Drug Administration (FDA)-regulated clinical research and the responsibilities of investigators, Institutional Review Boards (IRBs), and sponsors when an U.S. FDA-regulated product is utilized in a study. In particular, this module includes information on when an Investigational New Drug (IND) application is necessary and the requirements of the FDA Form 1572. A sub-module discusses the International Conference on Harmonisation (ICH) guidelines.

Language Availability English (ID: 12) Spanish (ID: 1493) Korean (ID: 15936) Chinese (ID: 1600) Khmer (ID: 16260) Vietnamese (ID: 15889)

Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) human subject protection regulations require institutions to have policies and procedures to ensure prompt reporting of unanticipated problems (UPs) involving risk to subjects or others to the Institutional Review Board (IRB), regulatory agencies, and appropriate institutional officials. In addition, FDA regulations require investigators to promptly report to the IRB all UPs involving risk to subjects or others and unanticipated adverse device effects. The purpose of this module is to provide guidance to investigators on complying with HHS and FDA reporting requirements by providing an overview of UPs, unanticipated adverse device effects, and the relationship between adverse events and UPs involving risk to subjects or others. As a part of the discussion, this module includes a discussion on how to detect UPs and how to report them.

Language Availability English (ID: 14777) Korean (ID: 15939) Vietnamese (ID: 16555)

Research and HIPAA Privacy Protections This module discusses the requirements of the Health Insurance Portability and Accountability Act (HIPAA) and how they supplement the U.S. Department of Health and Human Services (HHS) and FDA requirements. Situations where full HIPAA privacy protections are required and those that can qualify for waivers, alterations or exemptions with more limited requirements are discussed. This module also includes a discussion of the

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responsibilities of investigators and institutions for meeting HIPAA privacy requirements and for appropriate data security protections that are necessary to protect privacy.

Language Availability English (ID: 14) Korean (ID: 15942) Chinese (ID: 1725)

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Human Subjects Research – Social-Behavioral-Educational (SBE) Modules These basic modules provide an introduction to issues that arise in the context of SBE research involving human subjects.

Continuing Education (CE) Credits and Units These modules hold the following credit designations:

• Physicians: Up to 9 AMA PRA Category 1 Credits TM • Psychologists: 9 CEP Credits • Nurses: 6 CNE Credits/Contact Hours • Other Participants: 9 AMA PRA Category 1 Credits TM

Credit Designation Period:

• Physicians, Psychologists, and Other Participants: 1 July 2013 to 30 June 2016 • Nurses: 2 December 2013 to 2 December 2016

Module title Recommended Use

Belmont Report and CITI Course Introduction Required

History and Ethical Principles – SBE Required

Defining Research with Human Subjects – SBE Required

The Federal Regulations – SBE Required

Assessing Risk - SBE Required

Informed Consent - SBE Required

Privacy and Confidentiality - SBE Required

Research with Prisoners – SBE Supplemental

Research with Children – SBE Supplemental

Research in Public Elementary and Secondary Schools – SBE Supplemental

International Research – SBE Supplemental

Internet-Based Research - SBE Supplemental

Unanticipated Problems and Reporting Requirements in Social and Behavioral Research

Required

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Belmont Report and CITI Course Introduction This module provides a link to the Belmont Report. It also provides additional information regarding the CITI Program’s website and the availability of the Belmont Report in English, Chinese, Spanish, and French.

Language Availability English (ID: 1127) Spanish (ID: 16459) Korean (ID: 15895) Russian (ID: 16303) French (ID: 16448) Khmer (ID: 16273) Vietnamese (ID: 16241) Tamil (ID: 16384)

History and Ethical Principles – SBE This module discusses the evolution of the ethical principles in the U.S. that guide research design as well as the development of the federal regulations that govern the conduct of research relevant to researchers in the social and behavioral sciences. It reviews why ethics are necessary when conducting research involving human subjects including major historical events that have influenced how human subjects’ research is conducted. It describes problems with past studies that have violated ethical standards or have raised ethical concerns that have contributed to the national dialog related to the protection of human subjects. The Belmont Report principles are discussed as the basis for the ethical standards for research that guide us today.

Language Availability English (ID: 490) Spanish (ID: 16460) Korean (ID: 15896) Russian (ID: 16299) French (ID: 16449) Tamil (ID: 16377)

Defining Research with Human Subjects – SBE This module discusses an interpretation of definitions of the terms “human subject” and “research” with an emphasis on the interpretation for human subjects research in the social and behavioral sciences. Also included is a discussion as to the differences between private and public information and behavior, a critical aspect of many types of social and behavioral research. Language Availability English (ID: 491) Spanish (ID: 16461) Korean (ID: 15897) Russian (ID: 16294)

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French (ID: 16450) Khmer (ID: 15548) Vietnamese (ID: 16111) Tamil (ID: 16378)

The Federal Regulations – SBE This module provides an overview of the federal regulations and their basic provisions. A close reading of the regulations includes research methods and topics of inquiry relevant for researchers in the social and behavioral sciences and the humanities. Methods include surveys, interviews, focus groups, oral history, participant observation, observations of public behavior, and the analysis of existing data. This module provides specific examples of the ways in which the federal regulations are particularly pertinent to social and behavioral science researchers and the methodologies noted. In addition, regulatory information pertinent to social and behavioral researchers is covered, including the criteria for expedited and full board review and the authority of the Institutional Review Board (IRB).

Language Availability English (ID: 502) Spanish (ID: 16462) Korean (ID: 15898) Russian (ID: 16298) French (ID: 16451) Tamil (ID: 16379)

Assessing Risk - SBE This module discusses the challenges in identifying and evaluating risks associated with participation in social and behavioral sciences research. Unlike biomedical clinical trials, risks associated with social and behavioral science research are often elusive and less predictable. Topics include assessing risks, balancing risks and potential benefits, minimizing and managing risks, certificates of confidentiality, and ways to address risks in the informed consent document and process.

Language Availability English (ID: 503) Spanish (ID: 16463) Korean (ID: 15899) Russian (ID: 16295) French (ID: 16452) Khmer (ID: 16330) Vietnamese (ID: 16112) Tamil (ID: 16380)

Informed Consent – SBE This module discusses the process and documentation of informed consent, including informed consent guidelines as well as the required and additional elements of informed consent as described by the regulations. There is also a discussion of the circumstances

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under which an Institutional Review Board (IRB) may waive the requirements for informed consent with examples of how this is commonly applied in social and behavioral sciences research. This module also includes information related to recruitment, consent comprehension, timing of consent, and exculpatory language, topics that are important to the overall concept of informed consent.

Language Availability English (ID: 504) Spanish (ID: 16464) Korean (ID: 15900) Russian (ID: 16297) French (ID: 16453) Tamil (ID: 16381)

Privacy and Confidentiality – SBE This module defines privacy and confidentiality. It includes a discussion on protecting privacy in research and guidelines for designing confidentiality procedures. Topics include private versus public behavior, controlling access to private information, privacy and exempt research, privacy and research methods, confidentiality, privacy and reporting laws, and certificates of confidentiality. The discussion focuses on how these concepts apply to social and behavioral science research.

Language Availability English (ID: 505) Spanish (ID: 16465) Korean (ID: 15901) Russian (ID: 16296) French (ID: 16454) Khmer (ID: 15545) Vietnamese (ID: 16113) Tamil (ID: 16382)

Research with Prisoners – SBE This module describes the requirements for conducting research with prisoners. Included in the discussion is a review of the regulatory definition of a “prisoner,” the permitted categories of research involving prisoners and Institutional Review Board (IRB) review considerations. Importantly, this module contains a discussion on essential elements related to designing prisoner research, including consent issues and the assessment of risk. This module concludes with information related to accessing prisoner populations.

Language Availability English (ID: 506) Korean (ID: 15902) Research with Children – SBE This module describes regulations that apply to research with children. It defines “children” and discusses examples of research that meet the criteria of exempt research and expedited review and issues involved in obtaining and documenting parental permission and child

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assent. Included in the discussion is a review of the criteria for waiver of parental permission and/or child assent. Language Availability English (ID: 507) Spanish (ID: 16466) Korean (ID: 15903) French (ID: 16455)

Research in Public Elementary and Secondary Schools – SBE This module provides an overview of the types of public school research and the regulations that apply to research in these settings. Individual sections discuss the Family Educational Rights and Privacy Act (FERPA), the Protection of Pupil Rights Amendment (PPRA), and Subpart D at 45 CFR 46: Additional Safeguards for Children. Examples of activities that may qualify for exemption are discussed. This module concludes with a discussion of parental permission and child assent issues, as well as research-related harms to children and requirements for reporting observed child abuse and neglect. Language Availability English (ID: 508) Korean (ID: 15904)

International Research – SBE Social and behavioral scientists conduct research around the globe. This module includes a discussion of applicable regulations and guidelines and the importance of the local context. Because international research may also include collaborating institutions, this module provides information related to “engagement” in research. Additional topics include determining where research should be reviewed, exempt research, and informed consent considerations.

Language Availability English (ID: 509) Spanish (ID: 16467) Korean (ID: 15905) French (ID: 16456)

Internet-Based Research – SBE The Internet, with an estimated 2.3 billion users worldwide, has much to offer researchers, both as a research tool and as the object of study. This module presents the problems associated with obtaining consent online and explains why privacy and confidentiality may be of particular concern for Internet research. In addition, several problems with assessing risks of harm associated are included as it may often be difficult for investigators to assess these risks if they do not have previous experience with web-based research.

Language Availability English (ID: 510) Spanish (ID: 16468)

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Korean (ID: 15907) French (ID: 16457) Khmer (ID: 16331) Vietnamese (ID: 16114)

Unanticipated Problems and Reporting Requirements in Social and Behavioral Research This module defines unanticipated problems, describes the reporting requirements associated with unanticipated problems, and identifies the types of actions an Institutional Review Board (IRB) may take in response to an unanticipated problem.

Language Availability English (ID: 14928) Spanish (ID: 16469) Korean (ID: 15906) Russian (ID: 16300) French (ID: 16458) Tamil (ID: 16383)

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Human Subjects Research - Additional Modules of Interest These modules may be added to either HSR – Biomedical or SBE courses.

Continuing Education (CE) Credits and Units These modules hold the following credit designations:

• Physicians: Up to 9 AMA PRA Category 1 Credits TM • Psychologists: 9 CEP Credits • Nurses: 6 CNE Credits/Contact Hours • Other Participants: Up to 9 AMA PRA Category 1 Credits TM

Credit Designation Period:

• Physicians, Psychologists, and Other Participants: 1 July 2013 to 30 June 2016 • Nurses: 2 December 2013 to 2 December 2016

Module Title Recommended Use

Cultural Competence in Research Supplemental

Conflicts of Interest in Research Involving Human Subjects Required

Hot Topics Supplemental

Humanitarian Use Devices (HUDs) Supplemental

International Studies Supplemental

Consent Modules

Consent and Subject Recruitment Challenges: Remuneration

Supplemental

Consent in the 21st Century Supplemental

Consent Tools Used in Research Supplemental

Community- Engaged Research Modules

Introduction To Community-Engaged Research (CEnR)

Supplemental

Introduction to Community-Based Participatory Research (CBPR)

Supplemental

Ethical and Practical Considerations in Community-Engaged Research (CEnR)

Supplemental

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IRB-Focused Modules

External IRB Review Supplemental

I Have Agreed to be an IRB Community Member. Now What?

Supplemental

The IRB Administrator’s Responsibilities Supplemental

The IRB Member Module - "What Every New IRB Member Needs to Know”